Senior Clinical Trial Manager

Orukatx; Waltham (MA); Remote; USD 155,000 - 180,000; Full time

Job summary

An innovative firm is seeking a Senior Clinical Trial Manager to lead clinical trial initiatives for groundbreaking dermatology treatments. This position involves ensuring compliance with regulatory standards and operational efficiency while collaborating with cross-functional teams. The ideal candidate will have a strong background in clinical operations and a passion for making a meaningful impact in the field of chronic skin diseases. Join a vibrant team dedicated to transforming patient care and be part of a culture that values inclusivity and engagement. If you are ready to take on this challenge and contribute to advancing healthcare, this opportunity is for you.

Benefits

Competitive salary and benefits package

Opportunities for professional growth and development

Vibrant small-company culture

Qualifications

• 7+ years in clinical operations managing complex trials.
• Expertise in GCP and regulatory requirements essential.

Responsibilities

• Lead multiple clinical trials ensuring adherence to timelines.
• Manage trial budgets and negotiate contracts with vendors.

Skills

Clinical Trial Management

Regulatory Compliance

Budget Management

Leadership

Vendor Management

Education

Bachelor's degree in life sciences

Master's degree in life sciences

Job description

Oruka Therapeutics (Nasdaq: ORKA) is developing novel biologics designed to set a new standard for the treatment of chronic skin diseases. Oruka’s mission is to offer patients suffering from chronic skin diseases like plaque psoriasis the greatest possible freedom from their condition by achieving high rates of complete disease clearance with dosing as infrequently as once or twice per year. Oruka is advancing a proprietary portfolio of potentially best-in-class antibodies that were engineered by Paragon Therapeutics and target the core mechanisms underlying plaque psoriasis and other dermatologic and inflammatory diseases. We have raised nearly $500M since inception in February 2024 from top-tier investors and our first program is expected to be in the clinic in the first quarter of 2025. For more information, visit www.orukatx.com

As we build our core team, we're seeking top talent in different functional areas who are not just looking for a job, but an opportunity to be part of something bigger. Someone who is passionate about making a difference and eager to contribute to establishing an engaged, inclusive, and positive company culture.

Job Title: Senior Clinical Trial Manager

Location: Remote, expectation of travel 4 days a month

Role Overview:

The Senior Clinical Trial Manager serves as the clinical functional lead and will lead clinical trial initiatives for Oruka's cutting-edge dermatology treatments. You will ensure trial compliance, regulatory alignment, and operational efficiency while collaborating with cross-functional teams to advance Oruka's clinical pipeline. A Sr CTM is expected to independently manage the clinical trial by effectively planning and executing the study to ensure quality of deliverables within the specified budget and timeframe.

Key Responsibilities:

1. Clinical Trial Management:
1. Lead and manage multiple clinical trials from initiation through to completion, ensuring adherence to study timelines and budgets.
2. Collaborate with investigators, vendors, and cross-functional teams to ensure study execution and operational excellence.
3. Oversee the preparation and review of trial-related documentation, including protocols, informed consent forms (ICFs), case report forms (CRFs), and study reports.
4. In partnership with Program Management, develop and drive cross functional study timelines related to trial setup and execution.
5. Drive the cross functional internal study team ensuring appropriate alignment, risk management and coordination across all participating functions.
6. Successfully interface with Data Management, Biostatistics and Clinical Development to ensure seamless monitoring and data cleaning initiatives to meet study deliverables and timelines.
7. Foster a collaborative team environment focused on operational efficiency and continuous improvement.
2. Regulatory and Compliance Oversight:
1. Ensure that clinical trials are conducted in compliance with all applicable regulations, including FDA, EMA, and ICH-GCP guidelines.
2. Support the preparation and submission of clinical trial applications, including INDs, NDAs, and other regulatory documents with functional leads.
3. Manage interactions with Regulatory Affairs and external vendors to ensure timely submissions and approvals.
3. Budget and Resource Management:
1. Develop and manage clinical trial budgets, ensuring efficient use of resources and timely financial reporting.
2. Monitor and control trial costs to ensure alignment with project forecasts and company objectives.
3. Negotiate contracts and budgets with clinical vendors and investigators.
4. Vendor and Site Management:
1. Oversee the selection and management of clinical vendors (CROs, laboratories, etc.) and ensure they meet performance expectations.
2. Develop strong relationships with clinical sites and external partners to ensure aggressive site startup, high-quality data collection and trial conduct.
3. Perform risk assessment and management, addressing issues proactively to mitigate operational issues.

Qualifications:

• Bachelor’s or Master’s degree in life sciences or a related field.
• 7+ years of experience in clinical operations, with a focus on managing complex clinical trials.
• Expertise in GCP and regulatory requirements.
• Strong leadership and team management skills.

Compensation:

• An appropriate financial package will be developed for the successful candidate to include a competitive base salary and equity, with a performance-related bonus opportunity.
• The anticipated salary range for candidates, $155,000 to $180,000. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type and length of experience within the industry, education, etc. Oruka is a multi-state employer and this salary range may not reflect positions that work in other states.

Job Location:

• Position may be remote with the expectation to travel 4 days a month.

We're looking forward to hearing how you can contribute to our team and mission. Join us in shaping the future of our company and making a real impact every day.

What We Offer:

• A chance to be part of a vibrant small-company culture where your work can directly impact bringing new medicines to patients.
• Competitive salary and benefits package.
• Opportunities for professional growth and development.

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